An INtervention TO Improve MOBility of Older Hospitalized Patients

NCT05639231 | Completed

• 1 other identifier: 2022-01568
• Study Type: interventional
• Target: 383
• Locations: 1 country
• Sites: 4

Brief Summary

Low mobility during an acute care hospitalization is very frequent, particularly among older patients, and associated with adverse outcomes, such as persistent functional decline, institutionalization and death. However, increasing hospital mobility remains challenging because of the multiple existing barriers. The goal of this clinical trial is to test the effect of a multilevel intervention to increase hospital mobility, which addresses modifiable barriers and facilitators and does not require unavailable additional resources. This study aims to answer whether this intervention can improve mobility and patient-relevant outcomes such as life-space mobility and functional status. The multilevel intervention will target:

1. 1.The patients, who will receive an information booklet, a customizable diary, an exercise booklet and an iPad with access to the videos of the exercise booklet.
2. 2.The healthcare professionals (nursing staff and physicians) who will complete an e-learning, receive an oral presentation on the intervention, and receive a "mobility checklist" that reminds them of what they should assess daily regarding mobility.
3. 3.The hospital environment, where posters will be hung in the wards, including walking itineraries, on topics of interest to older adults.

Conditions

Hospital Mobility; Mobility Limitation; Life-Space; Functional Status; Hospital-Acquired Condition; Muscle Atrophy or Weakness; Sarcopenia; Iatrogenic Disease

Keywords

Hospital mobility; Life-Space; Functional status; Hospital-Acquired disability; Exercise; Movement; Ambulation

Outcome Measures

Primary Outcomes (1)

• Life-space level

  Measured by the University of Alabama at Birmingham Study of Aging Life-Space Assessment (range 0-120, with maximum being a higher score = better outcome). For patients institutionalized, assessment through the Life-Space Assessment in Institutionalized Settings. Both scales can be merged since the scoring is similar. Assessment by telephone interview of the participant/relatives.

  Day 30 (+/-5) after enrollment

Secondary Outcomes (46)

• Life-space level

  Day 180 (+/-5) after enrollment

• Activities of Daily Living

  Day 30 (+/-5) after enrollment

• Activities of Daily Living

  Day 180 (+/-5) after enrollment

• Instrumental Activities of Daily Living

  Day 30 (+/-5) after enrollment

• Instrumental Activities of Daily Living

  Day 180 (+/-5) after enrollment

Other Outcomes (3)

• Healthcare professional experience of the intervention and perspectives on hospital mobility

  After cluster closure (on average 1 to 10 months, maximum 15 months)

• Patient opinion on comfort and practicability of the StepWatch and GENEActiv accelerometers

  Discharge (-1 to +2 days after discharge)

• Patient opinion on comfort and practicability of the ActiGraph accelerometer

  Discharge (-1 to +2 days after discharge)

Study Arms (2)

INTOMOB intervention

EXPERIMENTAL

The intervention will be multilevel, targeting the patients, healthcare professionals (HCPs) and environment, as described under "Intervention description".

Behavioral: INTOMOB intervention

Control

NO INTERVENTION

Control procedure in the randomized trial: * Patients will receive standard of care, including physiotherapy if prescribed by the hospital physician and usual mobility recommendations and support by the HCPs. * HCPs will neither complete the e-learning, nor receive the checklist and the oral presentation. * The environment will not be modified in regards to mobility. Already existing information on this topic (e.g., small posters hanging in patient rooms) will not be removed, since it corresponds to current standard of care in some hospitals. In the pilot study, there will be no control procedure, since the objective is to assess experience and feasibility of the intervention, not its effects.

Interventions

INTOMOB intervention BEHAVIORAL

The intervention will be multilevel, targeting the patients, healthcare professionals (HCPs) and environment: PATIENTS: * Information booklet on the importance/benefits of mobility, consequences of low mobility, how to be more active (with concrete information). * Customizable diary to document mobility goals, results, difficulties and needs. * Exercise booklet with explanations \& pictures of mobility exercises (supine, sitting, standing). * iPad 10.2'' with videos of the exercises. HCPs (physicians \& nursing staff): * E-learning on the consequences of low mobility, barriers/facilitators to hospital mobility; recommendations, documentation, communication \& interdisciplinary collaboration regarding mobility; implementation. * Oral presentation on the intervention. * Checklist to remind HCPs to address mobility. ENVIRONMENT: * Posters in the wards about mobility and other topics of interest to older adults. * Walking itineraries in the wards.

INTOMOB intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to a general internal medicine (GIM) ward of a participating hospital
• Age ≥60 years
• Being ambulatory during the 2 weeks before admission (self-report)
• Living in the community (not in a nursing home or another institution) for at least the last 30 days prior to admission
• Ability to understand French or German
• Planned length of stay at least 3 days after enrollment
• For the pilot-study only: Possibility to start the study within 48 hours after admission to the GIM ward

You may not qualify if:

• Medical contraindication to walk (e.g., wound not allowing loading weight)
• Wheelchair-bound
• End-of-life
• Severe psychiatric disorder (severe depression, schizophrenia, psychosis)
• Delirium (according to the Confusion Assessment Method \[CAM\])
• \- Dementia (defined as Mini-Cog \<3)
• Cognitive impairment making impossible to use study material (=implement the intervention) and to understand and sign informed consent, based on clinical judgement, except if a proxy can be actively involved in the study and provides consent
• Severe visual impairment

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Swiss National Science Foundation: collaborator
• Hôpital Fribourgeois: collaborator
• Kantonsspital Baden: collaborator

Study Sites (4)

Kantonsspital Baden

Baden, Canton of Aargau, 5404, Switzerland

Location

HFR-Fribourg - hôpital cantonal

Villars-sur-Glâne, Canton of Fribourg, 1752, Switzerland

Location

Spital Tiefenau, InselGruppe AG

Bern, 3004, Switzerland

Location

Inselspital, Bern University Hospital, InselGruppe AG

Bern, 3010, Switzerland

Location

Related Publications (1)

• Mooser B, Bergsma D, Liechti FD, Baumgartner C, Gentizon J, Mean M, Wertli MM, Mancinetti M, Schmidt-Leuenberger J, Aubert CE. Impact of an INtervention to increase MOBility in older hospitalized medical patients (INTOMOB): Study protocol for a cluster randomized controlled trial. BMC Geriatr. 2023 Oct 31;23(1):705. doi: 10.1186/s12877-023-04285-3.

  PMID: 37907858 DERIVED

MeSH Terms

Conditions

Mobility Limitation; Iatrogenic Disease; Muscular Atrophy; Asthenia; Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Behavior

Study Officials

• Carole E Aubert, MD, MSc

  Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Complete blinding is difficult due to the nature of the intervention and the design (cluster randomization). To preserve blinding as much as possible, several strategies have been set. At the cluster level (healthcare professional intervention): Since rotation across wards happens at the physician level, but is rare at the level of the nursing staff, the healthcare professional intervention targets mostly nurses. The healthcare professionals will be informed to avoid speaking about the intervention with colleagues of other wards. At the patient level, differential information for candidates for the intervention or for the control group (the randomization group is known when first approaching candidates for participation because of the cluster design) will be provided. Candidates for the control group will receive only partial information without explaining the intervention. They will be informed orally at the end of the study about all aspects of the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In a first phase, the intervention will be pilot-tested in one ward of each hospital (no comparison group). In a second phase, it will be tested in a parallel design (cluster randomized controlled trial).

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 6, 2022
• Study Start: December 15, 2022
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After study completion
• Access Criteria: Upon reasonable request

Locations

CH (4)